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Seni­or Medi­cal Direc­tor — Cli­ni­cal­De­ve­lo­pe­ment

Vollzeit @Rand­stad (Schweiz) AG veröffentlicht 6 Stunden ago

Job-Beschreibung

Job­de­scrip­ti­on

For our cli­ent, a dyna­mic inter­na­tio­nal bio­tech­no­lo­gy com­pa­ny focu­sed on cli­ni­cal-stage deve­lo­p­ment, we recruit a:

Senior/Executive Medi­cal Direc­tor — Cli­ni­cal Deve­lo­pe­ment
Loca­ti­on: Based in Basel, Switz­er­land / Remo­te model

Respon­si­bi­li­ties:

  • Lead Cli­ni­cal Deve­lo­p­ment: Pro­vi­de cli­ni­cal and gene­ral medi­cal exper­ti­se throug­hout the enti­re deve­lo­p­ment pro­cess, ran­ging from the cli­ni­cal deve­lo­p­ment plan and pro­to­col deve­lo­p­ment to stu­dy con­duct, regu­la­to­ry submission(s), and pro­duct launch.
  • Pro­to­col Over­sight: Pro­vi­de expert input to cli­ni­cal stu­dies and over­see pro­to­col deve­lo­p­ment in col­la­bo­ra­ti­on with the partner’s glo­bal teams.
  • Regio­nal Stra­tegy: Take respon­si­bi­li­ty for pro­to­cols to iden­ti­fy regi­on-spe­ci­fic ope­ra­tio­nal issues for the ter­ri­to­ry and pro­vi­de medi­cal over­sight of cli­ni­cal pro­jects whe­re neces­sa­ry.
  • CRO Manage­ment: Act as the medi­cal moni­tor or pro­vi­de over­sight for CRO part­ners regar­ding medi­cal queries and issues.
  • Regu­la­to­ry Inter­ac­tion: Pro­vi­de medi­cal exper­ti­se during inter­ac­tions with regu­la­to­ry agen­ci­es.
  • Ven­dor Over­sight: Over­see ven­dors as nee­ded to ensu­re cli­ni­cal stu­dies suc­cessful­ly meet regu­la­to­ry sub­mis­si­on goals.
  • Exter­nal Enga­ge­ment: Attend inves­ti­ga­tor mee­tings and deli­ver cli­ni­cal pre­sen­ta­ti­ons as nee­ded. Proac­tively iden­ti­fy key inves­ti­ga­tors in the regi­on to cul­ti­va­te long-term col­la­bo­ra­ti­ons, and recruit/manage a regio­nal Cli­ni­cal Advi­so­ry Board if nee­ded.
  • Rela­ti­onship Buil­ding: Estab­lish and main­tain appro­pria­te col­la­bo­ra­ti­ons and rela­ti­onships with exter­nal sci­en­ti­fic experts, thought lea­ders, and the gene­ral medi­cal com­mu­ni­ty.

Your Back­ground:

  • Edu­ca­ti­on: Medi­cal Doc­tor degree or Mas­ter degree in a rele­vant the­ra­peu­tic area.
  • The­ra­peu­tic Focus: Rele­vant are­as include Non-onco­lo­gy, CV, Immu­no­lo­gy, Spe­cial, Obe­si­ty, CNS, Mus­cle, etc
  • Expe­ri­ence: At least 5–10 years of expe­ri­ence in cli­ni­cal deve­lo­p­ment or a phar­maceu­ti­cal medi­cal func­tion.
  • Regu­la­to­ry Expe­ri­ence: Pre­vious expe­ri­ence in IND/NDA sub­mis­si­on and inter­ac­ting with regu­la­to­ry aut­ho­ri­ties is pre­fer­red.
  • Soft Skills: Good com­mu­ni­ca­ti­on skills and pre­sen­ta­ti­on skills.
  • Lan­guages: Flu­ent in Eng­lish (writ­ten and ver­bal).

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