Medi­cal Pro­gram Lea­der

Vollzeit @CDR Life Inc. veröffentlicht 12 Stunden ago

Job-Beschreibung

Leads the cli­ni­cal deve­lo­p­ment of pro­grams from can­di­da­te to com­ple­ti­on of ear­ly pha­se tri­als

We are loo­king for a cli­ni­cal tri­al phy­si­ci­an with at least 3 years of expe­ri­ence from phar­ma / bio­tech in start­ing up and lea­ding Pha­se 1 tri­als in solid tumour onco­lo­gy.

Key Respon­si­bi­li­ties

  • Lead the cli­ni­cal deve­lo­p­ment of onco­lo­gy pro­grams from IND/CTA sub­mis­si­on to com­ple­ti­on of ear­ly-pha­se tri­als.
  • Deve­lop and exe­cu­te cli­ni­cal tri­al pro­to­cols, inclu­ding input into the Data Manage­ment Plan, Inves­ti­ga­tor Bro­chu­re, and Annu­al Safe­ty Reports.
  • Ser­ve as the pri­ma­ry phy­si­ci­an for ongo­ing and future ear­ly-pha­se tri­als.
  • Repre­sent the cli­ni­cal team in regu­la­to­ry agen­cy mee­tings and inter­ac­tions with exter­nal experts, advi­so­ry boards, and Safe­ty Data Moni­to­ring Boards.
  • Col­la­bo­ra­te cross-func­tion­al­ly with inter­nal and exter­nal col­le­agues in trans­la­tio­nal sci­ence, sta­tis­tics, regu­la­to­ry affairs, and phar­ma­co­ki­ne­tics.
  • Main­tain an exter­nal focus to under­stand key stake­hol­ders inclu­ding Health Aut­ho­ri­ties, Key Exter­nal Experts, Asso­cia­ti­ons, and Pati­ent Groups.

Who you are

  • MD, ide­al­ly with board cer­ti­fi­ca­ti­on in onco­lo­gy, and seve­ral years of direct pati­ent care expe­ri­ence.
  • At least 5 years of cli­ni­cal tri­al expe­ri­ence, inclu­ding IND sub­mis­si­ons and regu­la­to­ry inter­ac­tions.
  • Pro­ven track record in mana­ging all cli­ni­cal aspects of Pha­se 1 and Pha­se 2 onco­lo­gy tri­als.
  • Stra­te­gic thin­ker with a hands-on, prag­ma­tic approach to tri­al exe­cu­ti­on.
  • Expe­ri­en­ced in bio­mar­ker-dri­ven pati­ent sel­ec­tion and assay deve­lo­p­ment (e.g., IHC, RNA-Seq).
  • Strong com­mu­ni­ca­tor, adap­ta­ble, and high­ly col­la­bo­ra­ti­ve team play­er.
  • Bio­tech expe­ri­ence and know­ledge of acce­le­ra­ted appr­oval stra­te­gies are a plus.

Why CDR-Life?

Enter a meaningful job with pur­po­se hel­ping peo­p­le with can­cer and other incura­ble dise­a­ses. Beco­me part of a team on a mis­si­on with a col­la­bo­ra­ti­ve, open, and solu­ti­on-ori­en­ted spi­rit whe­re you can have an impact. Enjoy exci­ting oppor­tu­ni­ties for deve­lo­p­ment and pro­fes­sio­nal growth within our gro­wing orga­niza­ti­on with fle­xi­bi­li­ty that fits with your needs and life­style, as well as com­pe­ti­ti­ve sala­ry and bene­fits.

To app­ly or in case of ques­ti­ons, plea­se cont­act . We are loo­king for­ward to hea­ring from you.

CDR-Life is proud in its com­mit­ment to crea­ting a diver­se work­force and pro­vi­ding equal employ­ment oppor­tu­ni­ties to all employees and appli­cants wit­hout regard to reli­gi­on, sex, sexu­al ori­en­ta­ti­on, gen­der iden­ti­ty, gen­der expres­si­on, paren­tal sta­tus, natio­nal ori­gin, age, disa­bi­li­ty, citi­zen­ship sta­tus, gene­tic infor­ma­ti­on or cha­rac­te­ristics, marital sta­tus or any other cha­rac­te­ristic pro­tec­ted by law.

Plea­se note CDR-Life ope­ra­tes a strict­ly con­trol­led list of pre­fer­red recruit­ment part­ners. For tho­se part­ners who have no valid, signed Mas­ter Ser­vice Agree­ment in place with CDR-Life, all unso­li­ci­ted resu­mes, CVs, anony­mous pro­files, or any other can­di­da­te details sub­mit­ted through our web­site or to per­so­nal e‑mail accounts of employees of CDR- are con­side­red the pro­per­ty of CDR-Life and are not sub­ject to pay­ment of any form of intro­duc­tion, pla­ce­ment, or refer­ral fees.

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